Certainty from Planning to the Final Report
IVD Study Management & Monitoring with TRIGA-S
TRIGA-S supports your study management from planning through the final report. We deliver audit- and submission-ready study documentation in compliance with ISO 20916, IVDR, and CFR.
All our services can be booked individually or as a complete package – precisely according to your needs.
Your Benefits with TRIGA-S
Regulatory Security from Day One
Your study meets all current requirements: ISO 20916:2024, IVDR, and CFR. We know the pitfalls and proactively eliminate them.
Audit-Proof Data Quality
Complete, traceable documentation (TMF/eTMF), risk-based monitoring, and real-time dashboards give you continuous oversight and data integrity that stands up to any audit.
Faster Market Access
Structured data collection forms, careful site selection before study start, and thorough preparations by our well-coordinated team shorten setup times and minimize rework.
No Expensive Delays
We identify risks early, preventing unnecessary project delays. This keeps your processes predictable and avoids expensive surprises.
Our services in detail
Study Management & Monitoring
All services at a glance – jump straight to the topic you need.
Study Design & Planning
First steps count. A well-conceived, scientifically sound study design based on current literature and regulatory requirements is the foundation for your success.
We integrate data collection, monitoring, and analysis into one streamlined workflow for these study types:
- Exploratory Study
- Feasibility Study
- Sample Collection Study
- Analytical Performance Study
- Clinical Performance Study
- Companion Diagnostics (CDx) Study
- Usability Study
- Post-Market Performance Follow-up Study
“Across all study types, we apply risk-based planning and oversight to focus on what matters most – optimizing resource use and supporting efficient, reliable execution.”
– Dr. Lisa Mutschelknaus, Head of Study Management
Study Preparation
A study’s success is not determined during sample analysis, it is shaped long before. Our preparation sets the foundation for efficient execution, regulatory acceptance and systematically reduces follow-up questions from authorities and ethics committees.
We create all necessary documents according to current standards – compliant, complete, and on time for a successful study start.
Site Selection and Management
A study only succeeds with sites that truly fit your requirements. That’s why structured site management matters—it supports reliable site selection and hands-on site support throughout.
While protocols and regulations form the foundation, the people and processes on site determine recruitment, data quality, and ultimately the study’s success.
We support you from site identification to the final study report, ensuring you have the right partners on board.
Suitable Study Sites
We identify the right study sites for your clinical performance study based on the target group, geographical requirements, and professional specializations.
Capacities
We systematically assess equipment, resources, and capacity to ensure each site meets your requirements.
Cross-Site Coordination
We ensure recruitment, sample flows, and data quality across all sites.
Presence
Our CRAs (Clinical Research Associates) ensure compliance through close contact with study sites and targeted on-site visits.
Study Monitoring
Monitoring ensures data quality and regulatory compliance. With TRIGA-S, you maintain an overview of your study data at all times.
Our monitoring expertise for your study:
Clear Monitoring Plans
We define the scope, frequency, and priorities of monitoring – risk-based and efficient.
Complete Documentation
We manage your Trial Master Files (TMF/eTMF) and ensure a complete, auditable documentation set.
Systematic Site Visits
Our site initiation, monitoring and close-out visits help ensure compliance and data quality at each site.
Source Data Verification (SDV)
We verify the consistency between source data and collection – audit-ready.
Professional Query Management
We provide ongoing support for your data capture system, perform plausibility checks and data cleaning to ensure high data quality and fast query turnaround.
Real-Time Transparency
Dashboards provide real-time status on recruitment, completeness, and deviations.
Central Data Collection
Save time by letting us handle the data capture for clearly defined components (central lab/logistics data, transcription, data imports) – including training and support for study sites to reduce errors and shorten turnaround times.
Regulatory Support
The regulatory landscape is complex – keeping track of IVDR, FDA requirements, and national specifics is a challenge.
We guide you through the regulatory landscape and help keep your conformity assessment predictable.
The Challenge
Complex authority requirements and regulatory specifications
Our Solution for You
Complete, submission-ready documents for ethics committees and authorities.
The Challenge
Returns and delays due to incomplete documents
Our Solution for You
Scientific consultations with BfArM, PEI, and FDA to precisely clarify requirements and minimize delays.
The Challenge
Uncertainty in implementing requirements from IVDR or MDCG documents
Our Solution for You
Classification and IVDR gap analyses of your technical documentation to ensure IVDR conformity and make CE marking predictable.
The Challenge
FDA market entry for USA expansion
Our Solution for You
Comprehensive support in meeting FDA requirements for successful US market entry.
“Overlooking one critical detail in the planning phase can send your regulatory strategy off course – and the effects can ripple through the entire project. At TRIGA-S we set the right direction early: with structured planning and meticulous attention to detail.”
– Dr. Stefanie Gaupp, Team Lead Study Management
Study Completion and Reporting
Studies don’t end with the last measurement. We close them properly – database closure, final verified datasets, and a Performance Study Report suitable for technical documentation. The result: a strong basis for conformity assessment, audits, and post-market activities.
You receive:
- Performance Study Report according to regulatory standards for your technical documentation
- Database Closure with final, verified datasets
- Complete traceability for audits and regulatory inspections
Data Quality and Data Protection Standards
Across all our services, we adhere to relevant quality and compliance standards
ALCOA++
GDPR-Compliant Hosting (Servers in Germany/EU)
Complete Traceability of All Processes
Integrity, Availability, and Compliance in Every Data Processing Step
True Partnership is the Foundation for Strong Study Results
“Patients, physicians, researchers – every study is backed by people who rely on precise results. That’s why we treat every project as a true partnership, built on trust and scientific precision. Let’s talk about your study.”
– Dr. Andreas Franke, Managing Director
Get in touch with us
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Email Address
info@triga-s.de
Phone Number
Address
Mühltal 5, 82392 Habach
Contact Form
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Abbreviations
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
APSP: Analytical Performance Study Plan
BfArM: Federal Institute for Drugs and Medical Devices
CDx: Companion Diagnostics
CE: European Conformity
CFR: Code of Federal Regulations
CPSP: Clinical Performance Study Plan
CRA: Clinical Research Associate
DMP: Data Management Plan
GDPR: General Data Protection Regulation
eCRF: Electronic Case Report Form
EDC: Electronic Data Capture
eTMF: Electronic Trial Master File
EU: European Union
FDA: Food and Drug Administration
ICF: Informed Consent Form
ISO: International Organization for Standardization
IVD: In vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
MDCG: Medical Device Coordination Group
PEI: Paul-Ehrlich-Institut
SDV: Source Data Verification
TMF: Trial Master File
US: United States